Exer Labs, Inc.

Warning LetterOpen

Zaw L. Thet Chief Executive Officer Exer Labs, Inc. 383 Corona Street Denver , CO 80218 United StatesFEI 3020929899Issued Feb 10, 2025Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3020929899.

Violations10

Issue DateFeb 10, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Exer Labs, Inc.
Location: Zaw L. Thet Chief Executive Officer Exer Labs, Inc. 383 Corona Street Denver , CO 80218 United States
FEI Number: 3020929899
Country: United States
Issue Date: February 10, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Exer Labs, Inc. was warned for manufacturing the Exer Scan, a medical device intended for diagnosing and treating musculoskeletal and neurological disorders using artificial intelligence algorithms, without obtaining required premarket approval (PMA) or investigational device exemption (IDE) authorization. The company violated federal law by marketing the device for diagnostic and therapeutic uses that exceeded the exemptions allowed for standard exercise measurement equipment, and failed to submit a premarket notification (510(k)) before commercial distribution. The FDA's October 2024 inspection of the Denver facility identified that the device was adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act due to these missing regulatory approvals and the undisclosed change in intended use.

Exer Labs, Inc. FDA Warning Letter, February 10, 2025